Preparing for Stronger Regulations

Six Minutes

The following previously appeared on Industry Today’s blog.

As manufacturers wrestle with Food Safety and Modernization Act compliance, there is no denying one simple truth:projects once the regulatory genie is out of the bottle, there’s no turning back. Regulations rarely become less stringent, and inspections and audits rarely become simpler over time.

Waiting until the Food and Drug Administration has fully codified the rules and begun enforcement is not the time to start implementing your compliance plan. At Kepner-Tregoe, we have seen too many organizations caught in a cycle of catch-up, leading to skyrocketing costs of compliance and panicked goose chases for data, while managers (Quality and otherwise) get bound by bureaucratic red tape.

This was underscored at September’s (2013) Food Quality Symposium in Phoenix, Arizona, by Dr. David Acheson, director of the Food and Import Safety Practice at Leavitt Partners, and the former chief medical officer for both the FDA and the U.S. Department of Agriculture’s Food Safety and Inspection Service, and Sarah Geisert, Senior Director, Global Product Safety and Regulatory Affairs at General Mills.

Planning and organizing for the new regulatory environment – and properly implementing those plans – can be the difference between success and suicide. Not only in terms of regulatory, but in our current world where social media is a public relations behemoth, there cannot be a single misstep in terms of regulatory or market perception when it comes to food safety. As Dr. Acheson cautions, when things go badly with the FDA and USDA; that is a headache. When things go badly with our customers; that is the end.

So how do manufacturers stay ahead of the curve when compliance rears its head? We hear consistently how critical documentation is; but documentation is not the means to the end. Sarah Geisert stated it most clearly, “You have to have process.” She, and we at Kepner-Tregoe, define this as “the walk;” involving the right people, at the right time, in the right way, to ensure each person is doing the right thing. Clear, consistent thinking drives success – across different levels of the organization, across different functional areas, even across different locations.

Facilities that have thought clearly about how to operate under the new rules and have executed rational processes in preparation, will be in better stead. With a solid corrective action mindset in place, audits and exceptions can be treated as individual, manageable episodes – not devastating and distracting sagas, wrought by an unreasonable watchdog.

listeriaShawn Stevens, National Food Safety attorney submits this theory: Access to records is needed for the FDA to determine if your product is a risk. Visible, transferable process can help you operate and perform. Further, the Agency may conclude from your records whether or not you are at risk.

As so many people asked at the symposium, “What tools do we need to effectively plan, organize, and implement for success?” “How do we get ahead – particularly in a world where resources are limited and time is precious?” “How do we ensure that our thinking is robust enough and consistently applied?”

We have found there are four phases where thinking clearly will provide manufacturers a key competitive advantage:

1.   Building a Plan

Effective preventive action plans define a framework for avoiding issues and provide a “safety net” to get back on track before incidents become problems. When we asked one Director of Quality to describe his role as he sees it, he replied without blinking, “Keep the CEO out of jail.” While that may seem tongue-in-cheek on one level, it also underscores the zero-tolerance environment of food safety, which requires diligence and focus across the organization.

Identifying —asking “What could go wrong?”—results in an understanding of potential risks and their likelyppa-blended-background causes. Once prioritized, assigning preventive actions against these causes reduces their likelihood. A thorough analysis also delineates appropriate contingent actions to minimize the impact, should something go wrong. Setting proper triggers for action ensures this backup plan isn’t gathering dust on your shelf while troubleshooters swarm in a panic.

Protecting quality is not the Quality Department’s job. It’s everyone’s job. Knowing how to Manage Involvement – whether to be autocratic or democratic, when to manage by consensus or fiat – is crucial. Well-orchestrated involvement of people leads to the high level of commitment that moves an organization toward common goals.

2.   Implementing the Plan

Even the most brilliant plan offers no value unless it is implemented. Good Project Management techniques at this stage help clarify and build agreement around the action plan’s scope and purpose. Effective teams know ahead of time what the plans will accomplish – and what they won’t. Project planning identifies resources and optimizes schedules.

Following our previous analysis of Potential Problems, Quality managers can bullet-proof the plan’s implementation. Here, you can analyze “What can go wrong?” around resource (human, equipment, material) shortages, scheduling conflicts, personnel decisions, outside interference, and more; again, clear triggers will alert you if the project is in danger of missing its mark and will allow for appropriate corrective actions.

Project Management skills come into play to monitor progress against the plan and modify activities, as necessary, to ensure timely execution.

Operating under this new environment will require changes in peoples’ behavior – throughout all levels of the organization. Successful organizations understand that defining the Performance System correctly – setting clear expectations and removing roadblocks – is as critical to success as the employees’ skills and capabilities.

3.   Managing the Plan

Conditions change, and successful plans change with them. By using a systematic process to clarify concerns, agree on their relative priority, and ensure they are effectively resolved, the team can make sense of the shifting landscape.

A well-designed machine may be “set it and forget it” but people are not. Managing the Performance System at this point means providing pinpointed feedback and “balancing” the consequences, that is, making it easy to do the right thing becomes an ongoing function of leadership. The days of Command and Control – “Do it because I said so” – are long gone.

4.   Deviating from the Plan

The Number One concern we hear from food manufacturers – from the C-Suite to the plant floor – is, “We just don’t know how to troubleshoot effectively.” In the food safety environment, this is no small capability gap. As Stevens said and we all know, “Get to root cause to prevent outbreaks. Government and media, consumers and fruit-bowlcongress are all watching, so problem prevention is critical.” An effective root cause analysis process provides visibility into the “how to” of determining root cause—that thread of logic that auditors expect to find when examining investigation reports. By transferring these skills throughout your organization, your staff, using a shared language and common process, can collectively resolve critical business issues that continue to pay dividends over time.


While every company’s details and challenges are unique, in the food industry, the risks of getting it wrong are too high. Having a process that allows manufacturers to audit themselves is one of the critical factors of competitive advantage. Cross-functional preparedness, getting the right people involved in the right way, at the right time, doing the right things; these are common themes where using rational, clear-thinking processes can significantly reduce the stress and uncertainty currently felt.

Food safety professionals are the gatekeepers of brand equity. No silver bullets can eliminate all of the risks of running an operation. Thinking clearly through the issues and consistently applying common processes in a common language, throughout your organization, minimizes the chances that the Quality Department becomes both scapegoat and firefighter once these laws go into effect. As Theodora Monille-Hinds, Senior Director of Global Food Safety and Sanitation at Kellogg’s says, “FSMA should influence the way I think about safety, so that I can be ready for whoever shows up at my door.”







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